左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.167569775396757487523175340754820.31
216.227546974989752290.46
单位质量响应值RSD%判断
4670.924638.040.50数据可信
影响因素30天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批153414540355372458.3061.376.8856.94%～65.79%
253242533185328057.82
353781539355385858.45
458074578005793762.87
557012571125706261.92
663311635666343868.84
2024092121批156486565035649461.3164.217.4759.18%～69.24%
255543554555549960.23
355876556255575060.50
459385589525916864.21
561118610716109466.30
666850671746701272.72
l批165718652466548271.0675.2910.1467.28%～83.30%
266679667696672472.41
370403703217036276.36
459081595115929664.35
577121774267727483.86
677109771337712183.69
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.649747796289972989677796943969570.48
216.759735897608974830.19
单位质量响应值RSD%判断
5826.745819.880.09数据可信
影响因素30天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批1113706113401113554100.0398.883.5895.17%～102.59%
211089911106811098497.77
311201211230711216098.81
4113793113762113778100.23
510540610546310543492.88
6117337117786117562103.57
2024092121批111337811344811341399.9198.753.4795.16%～102.35%
211042811013711028297.15
311281711283011282499.39
4113749113374113562100.04
510566410531110548892.93
6117296116751117024103.09
l批1114515114613114564100.92101.092.4798.47%～103.71%
2116717116828116772102.87
3119238119468119353105.14
411176711174111175498.45
511280811296611288799.45
611326711312011319499.72
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.167802878772779647818477732781360.51
216.227715377059771060.09
单位质量响应值RSD%判断
4835.154753.761.21数据可信
影响因素30天-供试品溶液-左氨氯地平-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批159361596825952262.7162.326.2458.24%～66.40%
257457578805766860.76
355217551295517358.13
464563675986608069.62
558800584225861161.75
657954577725786360.96
2024092121批162383625426246265.8164.034.9360.72%～67.33%
257965586035828461.41
358082587315840661.54
466295657926604469.58
559463595305949662.68
660009598455992763.14
l批168272679286810071.7572.823.4670.17%～75.46%
268141678236798271.63
368948690136898072.68
470324700677019673.96
573211731797319577.12
666250661806621569.76
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.649753997631975009691297060973280.33
216.759773197815977730.07
单位质量响应值RSD%判断
5849.045837.190.15数据可信
影响因素30天-供试品溶液-叶酸-pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024092121批1114930114840114885100.86100.583.4796.93%～104.24%
210967710968910968396.30
3114797115063114930100.90
4117591117277117434103.10
5119995120016120006105.36
611029811061611045796.98
2024092121批1114711114579114645100.65100.253.6096.47%～104.03%
210935510949910942796.07
3114829115070114950100.92
4117023116927116975102.70
5119833119569119701105.09
610954810932310943696.08
l批110769510766410768094.5499.264.2594.83%～103.68%
2117262117571117416103.09
310960110955110957696.20
411068211083211075797.24
5119992120244120118105.46
611286211269011277699.01
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